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Adherence Connection for Counseling, Education, and Support (ACCESS) II

Adherence Connection for Counseling, Education, and Support (ACCESS) II

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04499781
Acronym
ACCESS
Enrollment
60
Registered
2020-08-05
Start date
2022-02-14
Completion date
2024-07-25
Last updated
2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Brief summary

The primary objective of the proposed clinical trial, Adherence Connection for Counseling, Education, and Support (ACCESS)-II, is to test the efficacy of ACCESS-II on antiretroviral treatment (ART) adherence and HIV-viral load in Black and Hispanic HIV-infected (HIV+) adolescents and young adults (AYA), ages 18-29 years (N=120) using a longitudinal (12 and 24 week outcomes), two-group, randomized control trial (RCT). Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral/motivational sessions for improved ART adherence. Participants in the control will connect asynchronously to a web-based HIV ART adherence education condition.

Detailed description

To achieve these aims, a longitudinal (12 and 24- week study outcomes), two-group, randomized control trial (RCT) is proposed in a sample population of 120 perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral47-50 motivational18 sessions for improved ART adherence. Participants in the control will connect asynchronously to a web-based HIV ART adherence education condition. Study participants will access the intervention and control conditions outside of the clinical setting using study funded smart phones. Self-reported adherence and viral load (extracted from the medical records) of study participants will be measured, and uploaded to RedCAP. ART knowledge, adherence self-efficacy, HIV stigma, social support, psychological distress, and substance use will be measured using survey measures. Statistical analyses will be computed to assess the potential impact of ACCESS on adherence and HIV viral suppression, and will also be computed to assess changes in ART knowledge, adherence self-efficacy, HIV stigma, social support, psychological distress, and substance use among participants in both the intervention and control conditions.

Interventions

BEHAVIORALACCESS II mHealth Intervention

Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.

BEHAVIORALACCESS II control condition

Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.

Sponsors

Jacobi Medical Center
CollaboratorOTHER
NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

The ACCESS II RCT uses a two group, parallel, longitudinal study design. Participants will be randomized to the ACCESS synchronous peer intervention or the asynchronous web-based HIV ART adherence control. Block randomization will be used; the randomization scheme will be developed by the biostatistician and implemented in Research Electronic Data Capture (REDCap) to ensure that assignment to treatment condition is evenly distributed within each site.

Eligibility

Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No

Inclusion criteria

for participation in this study are: * HIV seropositive status (perinatally and behaviorally infected youth) * Ages 18-29 years * English speaking * Currently being prescribed an antiretroviral treatment regimen * Evidence of virologic failure or (detectable quantitative HIV serum viral load\>200 copies/ml) * No neuro-cognitive deficits which would impede participation in videoconferencing sessions or completion of study measures

Design outcomes

Primary

MeasureTime frameDescription
Log10 Viral LoadBaselineMeasured to eliminate the potential for social desirability bias associated with self-reported adherence. Viral load data was extracted from the medical records of participants.
Self-Reported ART AdherenceBaseline3-day self-report of ART adherence was collected to describe subjective adherence behavior. Investigators will compute an cumulative average missed dose calculation: # of doses missed divided by total number of prescribed doses over the past 3 days. (scores range from 0 to 100%; higher scores = better adherence)
Annualized Change in Log10 Viral Load (Copies/mL)Baseline, Week 24Annualized change in log10 viral load is a useful metric for conveying change over time while accounting for varying time points and number of viral load data measurements. All available viral load data for study participants was included and some participants had more than 3 viral loads included.
Adherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES)BaselineAssessment of adherence self-efficacy. The HIV MT SES is a 26-item survey measure that uses an 10-point Likert scale (1=not confident; 10=completely confident) to assess HIV-medication taking self-efficacy belief and outcome expectancy. Higher scores indicate higher levels of self-efficacy.

Secondary

MeasureTime frameDescription
Number of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD)BaselinePost-traumatic stress disorder (PTSD) was measured with the Primary Care-PTSD Screen-5 (PC-PTSD). The PC-PTSD is a brief measure using four-items to screen for symptoms of PTSD (re-experiencing, numbness, hyperarousal and avoidance behaviors) in primary care or ambulatory settings. The total score is the number of Yes responses and ranges from 0-5. Higher scores indicate probable or positive screen for PTSD. A participant was considered to have trauma if they reported 3 or more trauma symptoms in the past month.
Social Support and Isolation Measured With the Adolescent Medicine Trials Network (ATN) iTech Short Measure of the Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship Scales - Companionship ScoreBaselineThe ATN short measure is a 20-item tool where each item is rated on a 5-point Likert scale (1-5). The Companionship subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.2-63.1 with a mean of 50 and standard deviation of 10; higher scores reflect greater companionship.
Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support ScoreBaselineThe ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Emotional Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.7-62.0 with a mean of 50 and standard deviation of 10; higher scores reflect greater emotional support.
Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support ScoreBaselineThe ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Informational Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.6-65.6 with a mean of 50 and standard deviation of 10; higher scores reflect greater informational support.
Knowledge About ART Measured With the HIV Treatment Knowledge ScaleBaselineThe HIV Treatment Knowledge Scale is a 21-item instrument that uses true and false questions to assess knowledge of adherence, side effects and antiretroviral resistance. The score is calculated as the number of correct responses; scores range from 0-21, where higher scores = increased knowledge.
Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation ScoreBaselineThe ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Social Isolation subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 34.8-74.2 with a mean of 50 and standard deviation of 10; higher scores reflect greater social isolation.
Tobacco - Lifetime UseBaselineSubstance use was assessed with a modified Adolescent Trials Network (ATN) measure designed for use in clinical settings. Presented as the number of participants with lifetime tobacco use.
Marijuana - Lifetime UseBaselineSubstance use was assessed with a modified Adolescent Trials Network (ATN) measure designed for use in clinical settings. Presented as the number of participants with lifetime marijuana use.
Alcohol - Lifetime UseBaselineSubstance use was assessed with a modified Adolescent Trials Network (ATN) measure designed for use in clinical settings. Presented as the number of participants with lifetime alcohol use.
Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support ScoreBaselineThe ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Instrumental Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 29.3-63.3 with a mean of 50 and standard deviation of 10; higher scores reflect greater instrumental support.
HIV Stigma Measured With the HIV Stigma ScaleBaselineThe HIV Stigma Scale is a 40-item questionnaire assessing HIV stigma. Each item is rated on a 4-point Likert scale ranging from 1-4. The total score is the sum of responses and ranges from 40 to 160; higher scores indicate a greater level of perceived HIV-related stigma.
Depression Measured With the Patient Health Questionnaire-9 (PHQ-9)BaselineDepression was measured with the Patient Health Questionnaire (PHQ-9). The PHQ-9 includes 9 items from the DSM-IV criteria for depression with scores on a 4-point Likert scale (0=not at all, 3=nearly every day). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater levels of depression.
Anxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7)BaselineGeneralized anxiety disorder (GAD) was assessed with the Generalized Anxiety Disorder-7 (GAD-7). The measure includes 7 items about symptoms in the past two weeks. Each item is rated on 4-point Likert scale from 0-3. The total score is the sum of responses and ranges from 0-21; higher scores indicate greater levels of anxiety.

Countries

United States

Participant flow

Participants by arm

ArmCount
ACCESS II mHealth Intervention
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
30
Control
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
30
Total60

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up23
Overall StudyWithdrawal by Subject20

Baseline characteristics

CharacteristicACCESS II mHealth InterventionTotalControl
Age, Continuous25 years
STANDARD_DEVIATION 3.51
24.95 years
STANDARD_DEVIATION 3.2
24.9 years
STANDARD_DEVIATION 2.9
Ethnicity (NIH/OMB)
Hispanic or Latino
13 Participants26 Participants13 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants34 Participants17 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
19 Participants37 Participants18 Participants
Race (NIH/OMB)
More than one race
4 Participants7 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants12 Participants7 Participants
Race (NIH/OMB)
White
2 Participants2 Participants0 Participants
Region of Enrollment
United States
30 participants60 participants30 participants
Sex: Female, Male
Female
16 Participants31 Participants15 Participants
Sex: Female, Male
Male
14 Participants29 Participants15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 30
other
Total, other adverse events
3 / 300 / 30
serious
Total, serious adverse events
8 / 305 / 30

Outcome results

Primary

Adherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES)

Assessment of adherence self-efficacy. The HIV MT SES is a 26-item survey measure that uses an 10-point Likert scale (1=not confident; 10=completely confident) to assess HIV-medication taking self-efficacy belief and outcome expectancy. Higher scores indicate higher levels of self-efficacy.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionAdherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES)6.8 score on a scaleStandard Deviation 2
ControlAdherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES)6.8 score on a scaleStandard Deviation 1.2
Primary

Adherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES)

Assessment of adherence self-efficacy. The HIV MT SES is a 26-item survey measure that uses an 10-point Likert scale (1=not confident; 10=completely confident) to assess HIV-medication taking self-efficacy belief and outcome expectancy. Higher scores indicate higher levels of self-efficacy.

Time frame: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionAdherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES)7.7 score on a scaleStandard Deviation 1.6
ControlAdherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES)7.4 score on a scaleStandard Deviation 1.3
Primary

Adherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES)

Assessment of adherence self-efficacy. The HIV MT SES is a 26-item survey measure that uses an 10-point Likert scale (1=not confident; 10=completely confident) to assess HIV-medication taking self-efficacy belief and outcome expectancy. Higher scores indicate higher levels of self-efficacy.

Time frame: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionAdherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES)8.0 score on a scaleStandard Deviation 1.4
ControlAdherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES)7.6 score on a scaleStandard Deviation 1.2
Primary

Annualized Change in Log10 Viral Load (Copies/mL)

Annualized change in log10 viral load is a useful metric for conveying change over time while accounting for varying time points and number of viral load data measurements. All available viral load data for study participants was included and some participants had more than 3 viral loads included.

Time frame: Baseline, Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

ArmMeasureValue (MEAN)
ACCESS II mHealth InterventionAnnualized Change in Log10 Viral Load (Copies/mL)-0.43 log10 copies/mL/year
ControlAnnualized Change in Log10 Viral Load (Copies/mL)-0.53 log10 copies/mL/year
Primary

Log10 Viral Load

Measured to eliminate the potential for social desirability bias associated with self-reported adherence. Viral load data was extracted from the medical records of participants.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionLog10 Viral Load3.50 Log10 Viral Load (Copies/mL)Standard Deviation 1.2
ControlLog10 Viral Load3.40 Log10 Viral Load (Copies/mL)Standard Deviation 1.4
Primary

Self-Reported ART Adherence

3-day self-report of ART adherence will be collected to describe subjective adherence behavior. Investigators will compute an average missed dose calculation: # of doses missed divided by total number of prescribed doses over the past 3 days. (scores range from 0 to 100%; higher scores = better adherence )

Time frame: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

ArmMeasureValue (NUMBER)
ACCESS II mHealth InterventionSelf-Reported ART Adherence76.77 Percentage of successful doses
ControlSelf-Reported ART Adherence80.33 Percentage of successful doses
Primary

Self-Reported ART Adherence

3-day self-report of ART adherence was collected to describe subjective adherence behavior. Investigators will compute an cumulative average missed dose calculation: # of doses missed divided by total number of prescribed doses over the past 3 days. (scores range from 0 to 100%; higher scores = better adherence)

Time frame: Baseline

ArmMeasureValue (NUMBER)
ACCESS II mHealth InterventionSelf-Reported ART Adherence56.67 Percentage of successful doses
ControlSelf-Reported ART Adherence58.7 Percentage of successful doses
Primary

Self-Reported ART Adherence

3-day self-report of ART adherence was collected to describe subjective adherence behavior. Investigators will compute an cumulative average missed dose calculation: # of doses missed divided by total number of prescribed doses over the past 3 days. (scores range from 0 to 100%; higher scores = better adherence)

Time frame: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-12 study activities and 2 were lost to follow-up.

ArmMeasureValue (NUMBER)
ACCESS II mHealth InterventionSelf-Reported ART Adherence74.64 Percentage of successful doses
ControlSelf-Reported ART Adherence71.79 Percentage of successful doses
Secondary

Alcohol - Lifetime Use

Substance use was assessed with a modified Adolescent Trials Network (ATN) measure designed for use in clinical settings. Presented as the number of participants with lifetime alcohol use.

Time frame: Baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ACCESS II mHealth InterventionAlcohol - Lifetime Use25 Participants
ControlAlcohol - Lifetime Use27 Participants
Secondary

Anxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7)

Generalized anxiety disorder (GAD) was assessed with the Generalized Anxiety Disorder-7 (GAD-7). The measure includes 7 items about symptoms in the past two weeks. Each item is rated on 4-point Likert scale from 0-3. The total score is the sum of responses and ranges from 0-21; higher scores indicate greater levels of anxiety.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionAnxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7)6.3 score on a scaleStandard Deviation 5.8
ControlAnxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7)7.3 score on a scaleStandard Deviation 5.9
Secondary

Anxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7)

Generalized anxiety disorder (GAD) was assessed with the Generalized Anxiety Disorder-7 (GAD-7). The measure includes 7 items about symptoms in the past two weeks. Each item is rated on 4-point Likert scale from 0-3. The total score is the sum of responses and ranges from 0-21; higher scores indicate greater levels of anxiety.

Time frame: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionAnxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7)5.0 score on a scaleStandard Deviation 5
ControlAnxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7)5.8 score on a scaleStandard Deviation 5.4
Secondary

Anxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7)

Generalized anxiety disorder (GAD) was assessed with the Generalized Anxiety Disorder-7 (GAD-7). The measure includes 7 items about symptoms in the past two weeks. Each item is rated on 4-point Likert scale from 0-3. The total score is the sum of responses and ranges from 0-21; higher scores indicate greater levels of anxiety.

Time frame: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionAnxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7)4.5 score on a scaleStandard Deviation 4.3
ControlAnxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7)6.0 score on a scaleStandard Deviation 5.6
Secondary

Depression Measured With the Patient Health Questionnaire-9 (PHQ-9)

Depression was measured with the Patient Health Questionnaire (PHQ-9). The PHQ-9 includes 9 items from the DSM-IV criteria for depression with scores on a 4-point Likert scale (0=not at all, 3=nearly every day). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater levels of depression.

Time frame: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionDepression Measured With the Patient Health Questionnaire-9 (PHQ-9)4.3 score on a scaleStandard Deviation 5
ControlDepression Measured With the Patient Health Questionnaire-9 (PHQ-9)5.6 score on a scaleStandard Deviation 5.5
Secondary

Depression Measured With the Patient Health Questionnaire-9 (PHQ-9)

Depression was measured with the Patient Health Questionnaire (PHQ-9). The PHQ-9 includes 9 items from the DSM-IV criteria for depression with scores on a 4-point Likert scale (0=not at all, 3=nearly every day). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater levels of depression.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionDepression Measured With the Patient Health Questionnaire-9 (PHQ-9)5.6 score on a scaleStandard Deviation 6.3
ControlDepression Measured With the Patient Health Questionnaire-9 (PHQ-9)7.7 score on a scaleStandard Deviation 6.2
Secondary

Depression Measured With the Patient Health Questionnaire-9 (PHQ-9)

Depression was measured with the Patient Health Questionnaire (PHQ-9). The PHQ-9 includes 9 items from the DSM-IV criteria for depression with scores on a 4-point Likert scale (0=not at all, 3=nearly every day). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater levels of depression.

Time frame: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionDepression Measured With the Patient Health Questionnaire-9 (PHQ-9)4.7 score on a scaleStandard Deviation 5.6
ControlDepression Measured With the Patient Health Questionnaire-9 (PHQ-9)5.7 score on a scaleStandard Deviation 5.1
Secondary

HIV Stigma Measured With the HIV Stigma Scale

The HIV Stigma Scale is a 40-item questionnaire assessing HIV stigma. Each item is rated on a 4-point Likert scale ranging from 1-4. The total score is the sum of responses and ranges from 40 to 160; higher scores indicate a greater level of perceived HIV-related stigma.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionHIV Stigma Measured With the HIV Stigma Scale100.1 score on a scaleStandard Deviation 21.1
ControlHIV Stigma Measured With the HIV Stigma Scale105.9 score on a scaleStandard Deviation 17.5
Secondary

HIV Stigma Measured With the HIV Stigma Scale

The HIV Stigma Scale is a 40-item questionnaire assessing HIV stigma. Each item is rated on a 4-point Likert scale ranging from 1-4. The total score is the sum of responses and ranges from 40 to 160; higher scores indicate a greater level of perceived HIV-related stigma.

Time frame: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionHIV Stigma Measured With the HIV Stigma Scale97.9 score on a scaleStandard Deviation 18.9
ControlHIV Stigma Measured With the HIV Stigma Scale103.3 score on a scaleStandard Deviation 17.8
Secondary

HIV Stigma Measured With the HIV Stigma Scale

The HIV Stigma Scale is a 40-item questionnaire assessing HIV stigma. Each item is rated on a 4-point Likert scale ranging from 1-4. The total score is the sum of responses and ranges from 40 to 160; higher scores indicate a greater level of perceived HIV-related stigma.

Time frame: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionHIV Stigma Measured With the HIV Stigma Scale96.9 score on a scaleStandard Deviation 21.4
ControlHIV Stigma Measured With the HIV Stigma Scale101.4 score on a scaleStandard Deviation 15.6
Secondary

Knowledge About ART Measured With the HIV Treatment Knowledge Scale

The HIV Treatment Knowledge Scale is a 21-item instrument that uses true and false questions to assess knowledge of adherence, side effects and antiretroviral resistance. The score is calculated as the number of correct responses; scores range from 0-21, where higher scores = increased knowledge.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionKnowledge About ART Measured With the HIV Treatment Knowledge Scale14.8 score on a scaleStandard Deviation 3.1
ControlKnowledge About ART Measured With the HIV Treatment Knowledge Scale14.5 score on a scaleStandard Deviation 3.2
Secondary

Knowledge About ART Measured With the HIV Treatment Knowledge Scale

The HIV Treatment Knowledge Scale is a 21-item instrument that uses true and false questions to assess knowledge of adherence, side effects and antiretroviral resistance. The score is calculated as the number of correct responses; scores range from 0-21, where higher scores = increased knowledge.

Time frame: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionKnowledge About ART Measured With the HIV Treatment Knowledge Scale15.5 score on a scaleStandard Deviation 3.4
ControlKnowledge About ART Measured With the HIV Treatment Knowledge Scale15.8 score on a scaleStandard Deviation 3.3
Secondary

Knowledge About ART Measured With the HIV Treatment Knowledge Scale

The HIV Treatment Knowledge Scale is a 21-item instrument that uses true and false questions to assess knowledge of adherence, side effects and antiretroviral resistance. The score is calculated as the number of correct responses; scores range from 0-21, where higher scores = increased knowledge.

Time frame: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionKnowledge About ART Measured With the HIV Treatment Knowledge Scale14.4 score on a scaleStandard Deviation 3.8
ControlKnowledge About ART Measured With the HIV Treatment Knowledge Scale14.8 score on a scaleStandard Deviation 3.3
Secondary

Marijuana - Lifetime Use

Substance use was assessed with a modified Adolescent Trials Network (ATN) measure designed for use in clinical settings. Presented as the number of participants with lifetime marijuana use.

Time frame: Baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ACCESS II mHealth InterventionMarijuana - Lifetime Use23 Participants
ControlMarijuana - Lifetime Use25 Participants
Secondary

Number of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD)

Post-traumatic stress disorder (PTSD) was measured with the Primary Care-PTSD Screen-5 (PC-PTSD). The PC-PTSD is a brief measure using four-items to screen for symptoms of PTSD (re-experiencing, numbness, hyperarousal and avoidance behaviors) in primary care or ambulatory settings. The total score is the number of Yes responses and ranges from 0-5. Higher scores indicate probable or positive screen for PTSD. A participant was considered to have trauma if they reported 3 or more trauma symptoms in the past month.

Time frame: Baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ACCESS II mHealth InterventionNumber of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD)11 Participants
ControlNumber of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD)11 Participants
Secondary

Number of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD)

Post-traumatic stress disorder (PTSD) was measured with the Primary Care-PTSD Screen-5 (PC-PTSD). The PC-PTSD is a brief measure using four-items to screen for symptoms of PTSD (re-experiencing, numbness, hyperarousal and avoidance behaviors) in primary care or ambulatory settings. The total score is the number of Yes responses and ranges from 0-5. Higher scores indicate probable or positive screen for PTSD. A participant was considered to have trauma if they reported 3 or more trauma symptoms in the past month.

Time frame: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ACCESS II mHealth InterventionNumber of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD)5 Participants
ControlNumber of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD)10 Participants
Secondary

Number of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD)

Post-traumatic stress disorder (PTSD) was measured with the Primary Care-PTSD Screen-5 (PC-PTSD). The PC-PTSD is a brief measure using four-items to screen for symptoms of PTSD (re-experiencing, numbness, hyperarousal and avoidance behaviors) in primary care or ambulatory settings. The total score is the number of Yes responses and ranges from 0-5. Higher scores indicate probable or positive screen for PTSD. A participant was considered to have trauma if they reported 3 or more trauma symptoms in the past month.

Time frame: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ACCESS II mHealth InterventionNumber of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD)4 Participants
ControlNumber of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD)4 Participants
Secondary

Social Support and Isolation Measured With the Adolescent Medicine Trials Network (ATN) iTech Short Measure of the Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship Scales - Companionship Score

The ATN short measure is a 20-item tool where each item is rated on a 5-point Likert scale (1-5). The Companionship subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.2-63.1 with a mean of 50 and standard deviation of 10; higher scores reflect greater companionship.

Time frame: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionSocial Support and Isolation Measured With the Adolescent Medicine Trials Network (ATN) iTech Short Measure of the Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship Scales - Companionship Score49.4 T-scoreStandard Error 2.8
ControlSocial Support and Isolation Measured With the Adolescent Medicine Trials Network (ATN) iTech Short Measure of the Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship Scales - Companionship Score48.0 T-scoreStandard Error 2.7
Secondary

Social Support and Isolation Measured With the Adolescent Medicine Trials Network (ATN) iTech Short Measure of the Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship Scales - Companionship Score

The ATN short measure is a 20-item tool where each item is rated on a 5-point Likert scale (1-5). The Companionship subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.2-63.1 with a mean of 50 and standard deviation of 10; higher scores reflect greater companionship.

Time frame: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionSocial Support and Isolation Measured With the Adolescent Medicine Trials Network (ATN) iTech Short Measure of the Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship Scales - Companionship Score50.1 T-scoreStandard Error 2.8
ControlSocial Support and Isolation Measured With the Adolescent Medicine Trials Network (ATN) iTech Short Measure of the Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship Scales - Companionship Score48.9 T-scoreStandard Error 2.8
Secondary

Social Support and Isolation Measured With the Adolescent Medicine Trials Network (ATN) iTech Short Measure of the Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship Scales - Companionship Score

The ATN short measure is a 20-item tool where each item is rated on a 5-point Likert scale (1-5). The Companionship subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.2-63.1 with a mean of 50 and standard deviation of 10; higher scores reflect greater companionship.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionSocial Support and Isolation Measured With the Adolescent Medicine Trials Network (ATN) iTech Short Measure of the Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship Scales - Companionship Score47.0 T-scoreStandard Error 2.7
ControlSocial Support and Isolation Measured With the Adolescent Medicine Trials Network (ATN) iTech Short Measure of the Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship Scales - Companionship Score46.9 T-scoreStandard Error 2.5
Secondary

Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Emotional Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.7-62.0 with a mean of 50 and standard deviation of 10; higher scores reflect greater emotional support.

Time frame: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score47.9 T-scoreStandard Error 2.8
ControlSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score46.7 T-scoreStandard Error 2.6
Secondary

Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Emotional Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.7-62.0 with a mean of 50 and standard deviation of 10; higher scores reflect greater emotional support.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score47.2 T-scoreStandard Error 2.8
ControlSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score46.7 T-scoreStandard Error 2.8
Secondary

Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Emotional Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.7-62.0 with a mean of 50 and standard deviation of 10; higher scores reflect greater emotional support.

Time frame: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score48.5 T-scoreStandard Error 2.7
ControlSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score47.9 T-scoreStandard Error 2.7
Secondary

Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Informational Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.6-65.6 with a mean of 50 and standard deviation of 10; higher scores reflect greater informational support.

Time frame: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score51.3 T-scoreStandard Error 2.8
ControlSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score49.3 T-scoreStandard Error 2.8
Secondary

Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Informational Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.6-65.6 with a mean of 50 and standard deviation of 10; higher scores reflect greater informational support.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score47.1 T-scoreStandard Error 2.7
ControlSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score47.7 T-scoreStandard Error 2.7
Secondary

Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Informational Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.6-65.6 with a mean of 50 and standard deviation of 10; higher scores reflect greater informational support.

Time frame: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score51.3 T-scoreStandard Error 2.8
ControlSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score50.2 T-scoreStandard Error 3
Secondary

Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Instrumental Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 29.3-63.3 with a mean of 50 and standard deviation of 10; higher scores reflect greater instrumental support.

Time frame: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score49.6 T-scoreStandard Error 3
ControlSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score48.8 T-scoreStandard Error 3
Secondary

Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Instrumental Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 29.3-63.3 with a mean of 50 and standard deviation of 10; higher scores reflect greater instrumental support.

Time frame: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score48.7 T-scoreStandard Error 3
ControlSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score47.3 T-scoreStandard Error 3
Secondary

Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Instrumental Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 29.3-63.3 with a mean of 50 and standard deviation of 10; higher scores reflect greater instrumental support.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score45.9 T-scoreStandard Error 2.8
ControlSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score44.0 T-scoreStandard Error 2.7
Secondary

Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Social Isolation subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 34.8-74.2 with a mean of 50 and standard deviation of 10; higher scores reflect greater social isolation.

Time frame: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score52.5 T-scoreStandard Error 3.3
ControlSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score52.7 T-scoreStandard Error 2.9
Secondary

Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Social Isolation subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 34.8-74.2 with a mean of 50 and standard deviation of 10; higher scores reflect greater social isolation.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score54.6 T-scoreStandard Error 2.9
ControlSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score56.3 T-scoreStandard Error 2.8
Secondary

Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Social Isolation subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 34.8-74.2 with a mean of 50 and standard deviation of 10; higher scores reflect greater social isolation.

Time frame: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
ACCESS II mHealth InterventionSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score50.7 T-scoreStandard Error 3.3
ControlSocial Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score52.0 T-scoreStandard Error 2.9
Secondary

Tobacco - Lifetime Use

Substance use was assessed with a modified Adolescent Trials Network (ATN) measure designed for use in clinical settings. Presented as the number of participants with lifetime tobacco use.

Time frame: Baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ACCESS II mHealth InterventionTobacco - Lifetime Use20 Participants
ControlTobacco - Lifetime Use20 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026